ClinicalTrials.gov
ClinicalTrials.gov Menu

ELLIPTA™ vs. MDI Inhaler Preference Study, in Adult Subjects With Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02135718
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : June 8, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
This is a multicenter, stratified, and randomized, open-label, placebo study in subjects with asthma to compare inhalers, ELLIPTA a new dry powder inhaler (DPI) and metered dose inhalers (MDI). This study is conducted to evaluate subject's preference of several inhaler-specific attributes individually between an existing MDI and the ELLIPTA a dry powder inhaler. Subjects who have not used the ELLIPTA inhaler in the past 6 months and their asthma must be controlled on their current therapy were enrolled. Subjects meeting the eligibility criteria will be stratified according to their current inhaler use (stable for the past 3 months): 1.) Currently using a DPI as an inhaled asthma controller therapy OR 2.) Currently using an MDI as an inhaled asthma controller therapy (No fluticasone MDI use in the last 3 months) OR 3.) Currently using no inhaled asthma controller therapy (this includes patients using a LTM and/or SABA only). Once stratified, eligible subjects were randomized (1:1) to one of two sequences for using the inhaler: ELLIPTA inhaler once daily in Period 1 followed by MDI twice daily in Period 2 or MDI twice daily in Period 1 followed by ELLIPTA inhaler once daily in Period 2 for for 5-9 days each. In addition, subjects will be randomly assigned (1:1 allocation) to receive one of two sets of questions: Version 1 presents response options in the order of ELLIPTA inhaler, MDI, No preference; Version 2 presents response options in the order of MDI, ELLIPTA inhaler, No preference. At the end of the second trial period, subjects answered questions which assessed their preference of inhaler attributes. ELLIPTA is a registered trademark of the GSK group of companies.

Condition or disease Intervention/treatment
Asthma Device: ELLIPTA inhaler Device: Placebo Inhalation Aerosol (MDI)

Study Type : Observational
Actual Enrollment : 288 participants
Time Perspective: Prospective
Official Title: A Preference Study of Inhaler Attributes Between Two Inhalers; ELLIPTA and MDI, in Adult Subjects With Asthma
Study Start Date : June 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort Intervention/treatment
Group 1
Subjects will use the ELLIPTA inhaler once daily for 5 to 9 days during the first period followed by the MDI inhaler twice daily for 5 to 9 days during the second period.
Device: ELLIPTA inhaler
ELLIPTA inhaler, placebo DPIwith 30 doses (2 strips with 30 blisters per strip containing lactose in strip first strip and Lactose blended with magnesium stearate in second strip)

Device: Placebo Inhalation Aerosol (MDI)
Placebo inhaler MDI will be supplied containing aerosol propellant

Group 2
Subjects will use the MDI inhaler twice daily for 5 to 9 days during the first period followed by the ELLIPTA inhaler once daily for 5 to 9 days during the second period.
Device: ELLIPTA inhaler
ELLIPTA inhaler, placebo DPIwith 30 doses (2 strips with 30 blisters per strip containing lactose in strip first strip and Lactose blended with magnesium stearate in second strip)

Device: Placebo Inhalation Aerosol (MDI)
Placebo inhaler MDI will be supplied containing aerosol propellant




Primary Outcome Measures :
  1. Number of participants with the indicated inhaler preference based on the number of steps needed to use the inhaler [ Time Frame: Up to Day 18 ]
    The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for MDI inhaler, and no preference) based on the number of steps needed to use the inhaler was summarized by prior inhaler use, by study inhaler use sequence, by preference question version and overall.


Secondary Outcome Measures :
  1. Number of participants with the indicated inhaler preference based on how easy it is to tell how many doses you have left [ Time Frame: Up to Day 18 ]
    The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for MDI inhaler, and no preference) based on how easy it is to tell how many doses you have left was summarized by prior inhaler use, by study inhaler use sequence, by preference question version and overall.

  2. Number of participants with the indicated inhaler preference based on the comfort of the mouthpiece [ Time Frame: Up to Day 18 ]
    The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for MDI inhaler, and no preference) based on the comfort of the mouthpiece was summarized by prior inhaler use, by study inhaler use sequence, by preference question version and overall.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Diagnosed and treated asthma patients aged 18 years or older
Criteria

Inclusion Criteria:

  • Informed consent: Subject must give their signed and dated written informed consent to participate; Subject understands and is willing, able, and likely to comply with study procedures and restrictions; Subject must be able to read, comprehend, and record information in English.
  • Age: >=18 years of age at Visit 1
  • Gender: Male or non-pregnant female subjects. Female subjects must not be pregnant at the time of Visit 1 based on the investigator's evaluation during medical history and physician examination.
  • Asthma Diagnosis: Asthma as defined by the National Institutes of Health
  • Reversibility of Disease: Demonstrated historical reversibility of >=12% and >=200 milliliter (mL) reversibility of forced expiratory volume in one second (FEV1) within 10-40 minutes following 2-4 inhalations of albuterol/salbutamol inhalation aerosol (or equivalent nebulized treatment with albuterol/salbutamol solution) within 24 months of Visit 1.
  • Ability to use Inhalers: Subjects must demonstrate the ability to correctly use the ELLIPTA and MDI inhalers.
  • Current asthma therapy: Subjects must be using one of the following three stable asthma therapies for at least 3 months prior to screening: a. Currently using a DPI as an inhaled asthma controller therapy; OR b. Currently using an MDI as an inhaled asthma controller therapy (No fluticasone MDI use in the last 3 months); OR c. Currently using no inhaled asthma controller therapy (this includes patients using a leukotriene modifiers (LTM) and/or short-acting beta2-agonists (SABA) as rescue only). All subjects will be allowed the concomitant use of their currently prescribed asthma treatment(s) throughout the study, including rescue albuterol MDI (SABA) as needed.

Exclusion Criteria

  • Pregnant: Women who are pregnant or lactating.
  • MDI daily controller therapy: Subjects using Fluticatsone propionate (fluticasone HFA) MDI during the last 3 months.
  • ELLIPTA USE: Subjects who used any ELLIPTA inhaler (e.g., participated in a clinical study of fluticasone furoate (FF) or FF/vilanterol (VI) or any component of them, or placebo) within 6 months (i.e., 180 days) prior to Visit 1.
  • Asthma Control: Subjects who in the investigator's judgment have poorly controlled or have unstable asthma.
  • Chronic Obstructive Pulmonary Disease (COPD): Subjects with a current primary diagnosis of COPD.
  • History of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
  • Asthma Exacerbation: Any asthma exacerbation requiring oral corticosteroids within 1 month of Visit 1. A subject must not have had any hospitalization for asthma within 3 months prior to Visit 1.
  • Concurrent Diseases/Abnormalities: Historical or current evidence of clinically significant uncontrolled disease including, but not limited to: cardiovascular disease, hepatic disease, renal disease, hematological disease, neurological disease, or pulmonary disease (including, but not confined to chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, bronchopulmonary dysplasia, and chronic obstructive pulmonary disease). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
  • Oropharyngeal Examination: A subject will not be eligible for the study if he/she has clinical visual evidence of oral candidiasis at Visit 1.
  • Investigational Medications: A subject must not have used any investigational drug within 30 days prior to Visit 1.
  • Drug Allergy: Known or suspected sensitivity to the constituents of the placebo dry powder inhaler or MDI (i.e. lactose or magnesium stearate).
  • Milk Protein Allergy: History of severe milk protein allergy.
  • Tobacco Use. Current smoker or a smoking history of 10 pack years or more (e.g. 20 cigarettes/day for 10 years)
  • Affiliation with Investigator's Site: A subject will not be eligible for this study if he/she is an immediate family member of the participating Investigator, sub-Investigator, study coordinator, or employee of the participating Investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135718


Locations
United States, California
GSK Investigational Site
Huntington Beach, California, United States, 92647
GSK Investigational Site
Newport Beach, California, United States, 92663
GSK Investigational Site
Vista, California, United States, 92083
United States, Florida
GSK Investigational Site
Aventura, Florida, United States, 33180
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21236
GSK Investigational Site
Bethesda, Maryland, United States, 20814
United States, Massachusetts
GSK Investigational Site
North Dartmouth, Massachusetts, United States, 02747
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55402
GSK Investigational Site
Plymouth, Minnesota, United States, 55441
United States, Ohio
GSK Investigational Site
Canton, Ohio, United States, 44718
United States, Oregon
GSK Investigational Site
Medford, Oregon, United States, 97504
United States, South Carolina
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78750
GSK Investigational Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02135718     History of Changes
Other Study ID Numbers: 201344
First Posted: May 12, 2014    Key Record Dates
Last Update Posted: June 8, 2016
Last Verified: June 2016

Keywords provided by GlaxoSmithKline:
ELLIPTA
Asthma
Inhaler preference
Fluticasone furoate
ELLIPTA inhaler
Dry Powder Inhaler

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases